Evaluating outpatient care versus hospitalization for patients with chest pain

CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain )

This study is testing whether a quick outpatient care plan for patients with moderate chest pain is better than being hospitalized for treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 502 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 3 sites (Detroit, Michigan and 2 other locations)
• Trial ID: NCT05897632 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of a rapid outpatient evaluation strategy against traditional hospitalization for patients experiencing moderate risk chest pain. Patients will be randomized in the Emergency Department to receive either outpatient follow-up or hospitalization for further evaluation. The outpatient approach, known as CARE-CP, focuses on timely follow-up within 72 hours to manage cardiovascular risk factors and determine the need for additional cardiac testing. The goal is to improve patient-centered outcomes while reducing healthcare costs and resource strain associated with unnecessary hospitalizations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older presenting with chest pain and moderate risk for acute coronary syndrome, as defined by specific clinical criteria.

Not a fit: Patients with conditions such as ST Elevation Myocardial Infarction or significant coronary artery disease will not benefit from this outpatient evaluation strategy.

Why it matters

Potential benefit: If successful, this approach could lead to safer, more efficient management of chest pain, reducing unnecessary hospitalizations and improving patient experiences.

How similar studies have performed: While there is limited prospective data on this specific outpatient approach, preliminary findings suggest that similar strategies may be effective for managing moderate risk patients.

Eligibility criteria

Inclusion Criteria:

* Age ≥21 years old
* Chest pain or Symptoms of acute coronary syndrome (ACS)
* Moderate risk of ACS (all of the below)
* Hear Score 4-6
* Non-Ischemic electrocardiogram (ECG)
* Two Troponin measures \< Sex-Specific Upper Reference Limit

  * Women \<15 pg/ml
  * Men \<20 pg/ml
* No prior coronary artery disease (CAD)

  * No Prior Myocardial Infarction (MI)
  * No Prior Coronary Revascularization Procedures
  * No Patients with ≥ 70% Obstructive Coronary Disease

Exclusion Criteria:

* ST Elevation Myocardial Infarction (STEMI) Activation
* ST Changes or new T-wave inversions ≥1mm on ECG
* Any Elevated Troponin Measure (Based on Sex-Specific 99th Percentile)
* Serial change between Troponin Measures (Delta) ≥5 pg/mL
* Stress Echocardiography, Nuclear Stress Test, Stress ECG, Stress Cardiac MRI, Coronary CT Angiogram (CCTA), Invasive Coronary Angiography (Cardiac Cath) within 1 year
* "Clean" CCTA or Cardiac Cath (0% stenosis in all vessels) within the past 2 years
* Chest Trauma
* Pregnancy
* Life Expectancy \< 1 year
* Other comorbid conditions requiring hospitalization
* Unstable Vitals (Blood Pressure \<90, Heart Rate \>120 or \<50, O2 Sat \<90%)
* End Stage Renal Disease; Dialysis or estimated glomerular filtration rate (eGFR) \<30 mL/min
* Transfers From Another Hospital
* Non-English Speaking
* Prisoners
* Prior Enrollment
* Already Enrolled in Other Interventional Trial

Where this trial is running

Detroit, Michigan and 2 other locations

• Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
• Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Simon Mahler, MD, MS — Wake Forest University Health Sciences
• Study coordinator: Lauren Koehler

Conditions Chest Pain; Acute Coronary Syndrome; Cardiovascular Diseases